[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Iceland\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":782},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,47,87,107,152,186,212,245,271,307,337,376,409,438,468,496,529,551,578,602,626,655,682,711,748],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100078039","product-performance-report-evaluate-long-term-reliability--performance-of-medtronic-marketed-cardiac-therapy-products-100078039",false,"NCT00271180","Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products","Medtronic CRDM Product Performance Report","PPR","Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.\n\nInclusion Criteria:\n\n• Subject or appropriate legal guardians provide written informed consent and\u002For authorization for access to and use of health information as required by an institution's IRB\u002FMEC\u002FREB\n\nAND one of the following must also apply:\n\n* Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application\n* Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data\n\nExclusion Criteria:\n\n* Subjects who are, or will be inaccessible for follow-up\n* Subjects with exclusion criteria required by local law (EMEA only)\n* Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant\n* Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded","ALL",{"count":20,"type":21},20000,"ESTIMATED","OBSERVATIONAL","The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.",[25,26,27,28],"Arrhythmia","Bradycardia","Heart Failure","Sinus Tachycardia",[30,31,32,33],"Cardiac Pacing","Implantable Cardioverter Defibrillator","pacemaker","Sinus Bradycardia","RECRUITING","2026-08-18",{"date":37,"type":38},"2026-08-20","ACTUAL",{"date":40,"type":38},"1983-01",{"date":42,"type":21},"2040-12",{"name":44,"class":45},"Medtronic","INDUSTRY",333,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100386119","phase-3-a-treatment-study-protocol-for-participants-0-45-years-with-acute-lymphoblastic-leukaemia-100386119","NCT04307576","A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia","ALLTogether1 - A Treatment Study Protocol of the ALLTogether Consortium for Children and Young Adults (0-45 Years of Age) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL)","Inclusion Criteria:\n\n* Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) according to the WHO-classification of Tumours of Haematopoetic and Lymphoid Tissues (Revised 4th edition 2017) and with a diagnosis confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.\n* Age 0 - \\\u003C 46 years (one day before 46th birthday) at the time of diagnosis with the exception of infants with KMT2A-rearranged (KMT2A-r) BCP ALL.\n* Patients with surface immunoglobulin negative (sIG-) BCP-ALL and an IG::MYC rearrangement, unless they have a concurrent BCL2\u002F6 rearrangement. T-ALL patients with MYC translocations.\n* Informed consent signed by the patient and\u002For parents\u002Flegal guardians according to country-specific age-related guidelines.\n* The ALL diagnosis should be confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.\n* The patient should be diagnosed and treated at a participating paediatric oncology or adult haematology centre in the participating countries.\n* The patient should be a resident in one of the participating countries on a permanent basis or should intend to settle in a participating country, for instance by an application for asylum. Patients who are visiting the country as tourists should not be included. However, returning expatriots with primary diagnosis abroad may be included if no treatment has been administered and the diagnostic procedures are repeated at a participating centre.\n* All women of childbearing potential (WOCBP) have to have a negative pregnancy test within 2 weeks prior to the start of treatment.\n* For each intervention\u002Frandomisation an additional set of inclusion-criteria is provided.\n\nExclusion Criteria:\n\n* Age \\\u003C 365 days and KMT2A-rearranged (KMT2A-r) BCP-ALL (documented presence of a KMT2A-split by FISH and\u002For a KMT2A fusion transcript).\n* Age \\>45 years at diagnosis.\n* Patients with a previous malignant diagnosis (ALL as a second malignant neoplasm - SMN).\n* Relapse of ALL.\n* Patients with mature B-ALL (as defined by surface IG positivity) or any patients with IG::MYC and a concurrent BCL2\u002F6 rearrangement.\n* Patients with Ph-positive ALL (documented presence of t(9;22)(q34;q11) and\u002For of the BCR::ABL fusion transcript). These patients will be transferred to an appropriate trial for t(9;22) if available.\n* Previously known ALL prone syndromes (e.g. Li-Fraumeni syndrome, germline ETV6 mutation), except for Down syndrome. Exploration for such ALL prone syndromes is not mandatory and patients in whom genetic work-up reveals a new germ-line mutation (index-cases) will remain in the study.\n* Treatment with systemic corticosteroids corresponding to (\\>10mg prednisolone\u002Fm2\u002Fday) for more than one week and\u002For other chemotherapeutic agents in a 4-week interval prior to diagnosis (pre-treatment).\n* Pre-existing contraindications to any treatment according to the ALLTogether protocol (constitutional or acquired disease prior to the diagnosis of ALL preventing adequate treatment).\n* Any other disease or condition, as determined by the investigator, which could interfere with the participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.\n* Women of childbearing potential who are pregnant at the time of diagnosis.\n* Women of childbearing potential and fertile men who are sexually active and are unwilling to use adequate contraception during therapy. Efficient birth control is required.\n* Female patients, who are breast-feeding.\n* Essential data missing from the registration of characteristics at diagnosis (in consultation with the protocol chair).\n* For each intervention\u002Frandomisation an additional set of exclusion-criteria is provided.","0 Years","45 Years",{"count":57,"type":21},6430,"INTERVENTIONAL",[60],"PHASE3","ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design.",[63],"Leukemia, Acute Lymphoblastic",[65,66,18,67,68,69,70,71,72,73,74,75],"Leukemia","Acute Leukemia","ALLTogether","Leukaemia","Inotuzumab ozogamicin","Besponsa","ALLTogether1","Blinatumomab","Blincyto","6-tioguanine","6-thioguanine","2026-08-11",{"date":78,"type":38},"2026-08-12",{"date":80,"type":38},"2020-07-13",{"date":82,"type":21},"2033-06",{"name":84,"class":85},"Mats Heyman","OTHER",137,{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":18,"minAge":54,"maxAge":55,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":105,"locationsCount":106},"100355680","a-treatment-protocol-for-participants-0-45-years-with-acute-lymphoblastic-leukaemia-100355680","NCT03911128","A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia","A Treatment Study Protocol of the ALLTogether Consortium for Infants, Children and Young Adults (0-45 Years of Age) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL): a Pilot Study","Inclusion Criteria:\n\n* Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) according to the WHO-classification of Tumours of Haematopoietic and Lymphoid Tissues (Revised 4th edition 2017) and with a diagnosis confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.\n* Age 0 - \\\u003C 46 years (one day before 46th birthday) at the time of diagnosis, with the exception of infants with KMT2A-r BCP ALL (see exclusion criteria below).\n* Patients with surface immunoglobulin negative (sIG-) BCP-ALL and an IG::MYC rearrangement, unless they have a concurrent BCL2\u002F6 rearrangement. T-ALL patients with MYC translocations.\n* Informed consent signed by the patient and\u002For parents\u002Flegal guardians according to country-specific age related guidelines\n* The ALL diagnosis should be confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.\n* The patient should be diagnosed and treated at a participating paediatric oncology or adult haematology centre in the participating countries.\n* The patient should be a resident in one of the participating countries on a permanent basis or should intend to settle in a participating country, for instance by an application for asylum. Patients who are visiting the country as tourists should not be included. However, returning expatriots and patients who intend to stay at least for the duration of the treatment with primary diagnosis abroad may be included if no treatment has been administered and the diagnostic procedures are repeated at a participating centre.\n* All women of childbearing potential (WOCBP) have to have a negative pregnancy test within 2 weeks prior to the start of treatment.\n\nExclusion Criteria:\n\n* Age \\\u003C 365 days and KMT2A-rearranged (KMT2A-r) BCP-ALL (documented presence of a KMT2A-split by FISH and\u002For a KMT2A fusion transcript). These patients will be transferred to an appropriate trial for infant KMT2A-r BCP-ALL, if available.\n* Age \\>45 years at diagnosis.\n* Patients with a previous malignant diagnosis (ALL as a second malignant neoplasm - SMN).\n* Relapse of ALL.\n* Patients with mature B-ALL (as defined by surface IG positivity) or any patients with IG::MYC and a concurrent BCL2\u002F6 rearrangement.\n* Patients with Ph-positive ALL (documented presence of t(9;22)(q34;q11) and\u002For of the BCR::ABL1 fusion transcript). These patients will be transferred to an appropriate trial for t(9;22) if available.\n* Previously known ALL prone syndromes (e.g. Li-Fraumeni syndrome, germline ETV6 mutation), except for Down syndrome. Exploration for such ALL prone syndromes is not mandatory and patients in whom genetic work-up reveals a new germ-line mutation (index-cases) will remain in the study.\n* Treatment with systemic corticosteroids corresponding to (\\>10mg prednisolone\u002Fm2\u002Fday) for more than one week and\u002For other chemotherapeutic agents in a 4-week interval prior to diagnosis (pre-treatment).\n* Pre-existing contraindications to any treatment according to the ALLTogether protocol (constitutional or acquired disease prior to the diagnosis of ALL preventing adequate treatment).\n* Any other disease or condition, as determined by the investigator, which could interfere with the participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.\n* Women of childbearing potential who are pregnant at the time of diagnosis.\n* Women of childbearing potential and fertile men who are sexually active and are unwilling to use adequate contraception during therapy. Efficient birth control is required, see section 18.9.\n* Female patients, who are breast-feeding.\n* Essential data missing from the registration of characteristics at diagnosis (in consultation with the protocol chair).",{"count":95,"type":21},500,"The pilot study collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new platform protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised trials included in the study-design.\n\nThe pilot study is implemented as a master protocol without study specific interventions, thus as an observational study. The pilot study is for countries\u002Fstudy-groups who intend to join ALLTogether1 (including experimental interventions). For these countries the pilot study is crucial to optimise diagnostics, registration systems, collaborations with vendors, logistics and data-checks before starting the main study.\n\nThe study only includes \"standard of care\" treatment included in the master protocol.",[63],[65,99,18,67,68],"Acute Lymphoblastic",{"date":101,"type":38},"2026-08-13",{"date":103,"type":38},"2019-08-29",{"date":82,"type":21},{"name":84,"class":85},57,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":116,"conditions":117,"keywords":123,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100268928","prospective-research-rare-kidney-stones-prorks-100268928","NCT02780297","Prospective Research Rare Kidney Stones (ProRKS)","ProRKS","Inclusion Criteria:\n\n1. Diagnosis of primary hyperoxaluria\n2. Diagnosis of enteric hyperoxaluria\n3. Diagnosis of Dent Disease\n4. Diagnosis of Cystinuria\n5. Diagnosis of adenine phosphoribosyltransferase deficiency (APRTd)\n6. Diagnosis of Lowe Syndrome\n7. Diagnosis of Dent Disease Carrier\n\nExclusion Criteria:\n\n1. Prior renal failure\n2. History of liver and\u002For kidney transplant.",{"count":115,"type":21},220,"The purpose of this study is to determine the natural history of the hereditary forms of nephrolithiasis and chronic kidney disease (CKD), primary hyperoxaluria (PH), cystinuria, Dent disease and adenine phosphoribosyltransferase deficiency (APRTd) and acquired enteric hyperoxaluria (EH). The investigator will measure blood and urinary markers of inflammation and determine relationship to the disease course. Cross-comparisons among the disorders will allow us to better evaluate mechanisms of renal dysfunction in these disorders.",[118,119,120,121,122],"Hyperoxaluria","Cystinuria","Dent Disease","Lowe Syndrome","Adenine Phosphoribosyltransferase Deficiency",[124,120,125,126,121,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141],"primary hyperoxaluria","enteric hyperoxaluria","cystinuria","Adenine phosphoribosyltransferase deficiency","PH","APRTd","APRT","hyperoxaluria","oxalate","oxalosis","PH type 1","PH type 2","PH type 3","Dents","Dent","Dent 1","Dent 2","APRT deficiency","2026-08-05",{"date":144,"type":38},"2026-08-07",{"date":146,"type":4},"2016-05",{"date":148,"type":21},"2028-07",{"name":150,"class":85},"Mayo Clinic",11,{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":18,"minAge":159,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":58,"phases":162,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100217003","aurora-aiming-to-understand-the-molecular-aberrations-in-metastatic-breast-cancer-100217003","NCT02102165","AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.","AURORA","Inclusion Criteria:\n\n1. Female or male ≥ 18 years with diagnosis of locally recurrent\u002Fadvanced BC not amenable to treatment with curative intent or MBC who have not received more than 1 line of systemic therapy (any type) in the metastatic setting.\n\n   Under protocol 4.0, eligible patients will be limited to locally recurrent\u002Fadvanced breast cancer not amenable to treatment with curative intent or MBC with:\n   * histopathology-confirmed TNBC as defined by ER \\\u003C1% and HER2 negative following ASCO-CAP guidelines\n   * ILC (either based on ILC morphology or negative E-cadherin expression confirmed by IHC). Mixed ILC\u002Finvasive ductal carcinoma are not eligible for the ILC cohort.\n   * late relapse BC (any subtype). Late relapse is defined as a patient with a radiologic or histologic confirmation of advanced or MBC relapse \\> 10 years from the primary BC diagnosis.\n2. Written informed consent prior to registration into the program.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n4. Availability of primary tumor tissue for research purposes.\n5. Patient must have a metastatic lesion accessible for biopsy and must agree with the biopsy procedure.\n\n   1. Up until protocol 3.0, up to 100 patients with bone-only metastasis have been included without a metastatic biopsy, if plasma samples have been collected at screening, and if the patient met all other eligibility criteria.\n   2. In protocol 4.0, metastatic tumor biopsies from bone lesions will be accepted provided that the chosen site of biopsy was not previously irradiated.\n   3. Brain tissue is accepted if it is obtained through surgical excision not planned for AURORA, but as part of the routine clinical practice.\n6. The biopsy of the metastatic lesion must be conducted either at the initial diagnosis of the BC relapse before the initiation of 1st line systemic therapy or at the 1st disease progression before initiation of a second line systemic treatment. There is no restriction in the type of therapeutic modality considered as 1st line systemic treatment, which can consist of any type of treatment administered after the diagnosis of the advanced BC relapse till the 1st disease progression thereafter.\n7. Biopsies obtained during routine clinical practice are accepted if both formalin-fixed paraffin-embedded (FFPE) and Frozen Tissue (FT) blocks were collected concurrently from the same metastatic lesion and if collected at the pre-specified timelines for AURORA.\n8. Availability of a whole blood, serum and plasma samples collected at the time of screening.\n9. Patient agrees to provide blood samples at regular intervals, from the screening as well as during the follow-up phase of the program.\n\nExclusion Criteria:\n\n1. The patient has received more than 1 line of systemic therapy (any type) in the metastatic setting.\n2. Patients who have received prior palliative radiotherapy to the only site that is accessible to biopsy.\n3. Presence of severe hematopoietic, renal, and\u002For hepatic dysfunction, including but not restricted to albumin \\\u003C 3 g\u002Fdl.\n4. Known increased risk of hemorrhage during biopsy procedure, as evaluated by the treating physician.\n5. Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.","18 Years",{"count":161,"type":21},1000,[163],"NA","This program initially aims to recruit 1300 breast cancer patients from a large number of hospitals across Europe. Eligible patients are those who are 18 or older, either female or male, and who have not received more than 1 type of treatment from the time metastases were discovered, metastasi(e)s has just been diagnosed or their disease has come back (disease relapse). Biopsy samples from both the primary and metastatic (or relapsed) tumor will be collected for central analyses, together with blood, serum and plasma samples. Any samples not analyzed immediately will be stored in an independent bio-repository to enable future (not yet defined) research aimed at better understanding metastatic breast cancer.\n\nIn summary, the main objectives of AURORA are to better understand the genetic aberrations in metastatic breast cancer and to discover the mechanisms of response or resistance to therapy, in order to ultimately identify the \"right therapy for each individual patient\". At the same time, patients with genetic aberrations that are being targeted by new drugs in development will be offered the possibility to participate in clinical trials, when approved and available in their countries. Ultimately, the aim of AURORA is to improve the outcomes of all patients diagnosed with metastatic breast cancer.",[166],"Metastatic Breast Cancer",[168,169,170,171,172,173,174,175],"Aurora","breast cancer","metastatic","molecular screening","targeted gene sequencing","molecular aberrations","exploratory","biomarker","2026-08-04",{"date":178,"type":38},"2026-08-06",{"date":180,"type":38},"2014-04",{"date":182,"type":21},"2031-03",{"name":184,"class":85},"Jules Bordet Institute",52,{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":18,"minAge":159,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":211},"100530666","micrornas-as-biomarkers-for-obstructive-sleep-apnea-100530666","NCT06189755","MicroRNAs as Biomarkers for Obstructive Sleep Apnea","MIR-OSA","Inclusion Criteria for Cases:\n\n* age 18-75 years\n* moderate-severe OSA (defined as AHI ≥15 events\u002Fhour)\n* willing to accept PAP therapy\n\nInclusion Criteria for Controls:\n\n* age 18-75 years\n* no OSA (defined as AHI \\\u003C5 events\u002Fhour)\n\nExclusion Criteria for Cases:\n\n* current use of PAP or other OSA treatments\n* home oxygen therapy\n* recent changes (within 3 months) to BP medications among those who are on these medications\n* presence of Cheyne-Stokes Respiration (CSR) in sleep study\n* predominantly central sleep apnea (AHI≥15 events\u002Fhour, with \\>50% central events)\n* pregnancy\n* clinical history of chronic kidney disease (Stage 5) requiring dialysis, or renal transplant\n* organ transplantation\n* self-reported sleep duration less than 5 hours per night on weeknights (work nights)\n* current night shift work\n\nExclusion Criteria for Controls:\n\n* home oxygen therapy\n* pregnancy\n* clinical history of chronic kidney disease (Stage 5) requiring dialysis, or renal transplant\n* organ transplantation\n* self-reported sleep duration less than 5 hours per night on weeknights (work nights)\n* current night shift work","75 Years",{"count":95,"type":21},"Although obstructive sleep apnea (OSA) is a common disorder, there are no blood biomarkers for identification and management of these patients. This project will study microRNAs in order to develop and validate blood biomarkers that are specific to OSA, useful for identification of cases with OSA, reflective of efficacy of therapy, and able to predict blood pressure response to treatment of OSA.",[197],"Obstructive Sleep Apnea",[199,200,201],"Sleep Apnea","Biomarkers","Blood pressure","2026-07-30",{"date":204,"type":38},"2026-08-03",{"date":206,"type":38},"2024-04-01",{"date":208,"type":21},"2028-04-30",{"name":210,"class":85},"University of Pennsylvania",3,{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":18,"minAge":159,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":58,"phases":222,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":244},"100632713","phase-3-an-open-label-extension-ole-study-following-completion-of-ctqj230a12301-to-evaluate-long-term-safety-and-tolerability-of-pelacarsen-tqj230-100632713","NCT07517263","An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)","A Single Arm, Multicenter, Open-label Extension (OLE) Trial to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Participants Who Completed the Parent Lp(a)HORIZON Trial","Inclusion Criteria:\n\n* Participants who have provided informed consent prior to initiation of any study-specific activities\u002Fprocedures.\n* Participants who have completed the parent study EOS visit while still on assigned investigational product.\n\nExclusion Criteria:\n\n* Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.\n* Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.\n* Participants are receiving another investigational drug or device before the open-label treatment period.\n* Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":221,"type":21},5700,[60],"This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).",[225],"Cardiovascular Disease and Lipoprotein(a)",[227,228,229,230,231,232,233,234,235],"Lipoprotein(a),","Lp(a),","cardiovascular disease,","CVD,","myocardial infarction,","stroke,","OLE,","pelacarsen,","open-label","2026-07-29",{"date":202,"type":38},{"date":239,"type":38},"2026-05-11",{"date":241,"type":21},"2030-01-09",{"name":243,"class":45},"Novartis Pharmaceuticals",643,{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":252,"sex":18,"minAge":159,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":270},"100436960","pancreatic-cancer-early-detection-consortium-100436960","NCT04970056","Pancreatic Cancer Early Detection Consortium","PRECEDE","Inclusion Criteria:\n\nIndividuals from the following groups who present for clinical evaluation and assessment of PDAC risk at any of the participating sites can be offered participation in the PRECEDE database:\n\nCohort 1\n\nIndividuals without history of PDAC meeting any of the following criteria:\n\n1. 2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; age 50+ or ≤10 years younger than earliest PDAC in family at time of diagnosis.\n2. 2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family\n3. BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family\n4. Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+\n5. Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+\n6. Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+\n\nCohort 2\n\nIndividuals without history of PDAC meeting any of the following criteria:\n\n1. ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+\n2. 2+ relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in family\n3. 1 first degree relative with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member\n\nCohort 3 Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2)\n\nCohort 4 Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort.\n\nCohort 5 Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and\u002For buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort.\n\nCohort 6a\n\nIndividuals diagnosed with PDAC or pancreatic high-grade dysplasia after enrollment in PRECEDE meeting any of the following criteria:\n\n1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other\n2. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11\n\nCohort 6b\n\nIndividuals with a personal history of PDAC or pancreatic high-grade dysplasia meeting any of the following criteria:\n\n1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other\n2. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11\n3. Diagnosed ≤ age 45\n\nCohort 6c Individuals with newly diagnosed early stage (stage I or stage II) PDAC seen at a PRECEDE site that do not meet the criteria for 6a or 6b.\n\nCohort 6d Individuals with PDAC seen at a PRECEDE site that do not meet the criteria for 6a, 6b, or 6c.\n\nCyst Cohort Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)\n\nExclusion Criteria:\n\n* Individuals not meeting the criteria above.",true,"90 Years",{"count":20,"type":21},"The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and\u002For individuals carrying pathogenic\u002Flikely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up.",[257,258,259,260],"Pancreas Cancer","Pancreas Cyst","Pancreatic Ductal Adenocarcinoma","Genetic Predisposition","2026-07-21",{"date":263,"type":38},"2026-07-22",{"date":265,"type":38},"2020-09-18",{"date":267,"type":21},"2030-12-31",{"name":269,"class":85},"Arbor Research Collaborative for Health",60,{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":18,"minAge":54,"maxAge":219,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":281,"conditions":282,"keywords":285,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},"100101856","rare-kidney-stone-consortium-patient-registry-100101856","NCT00588562","Rare Kidney Stone Consortium Patient Registry","Rare Kidney Stone Consortium Registry for Hereditary Kidney Stone Diseases","RKSC","Inclusion Criteria:\n\n* Individuals must have a definitive diagnosis of Primary Hyperoxaluria, Dent Disease, Cystinuria or APRT Deficiency.\n* Individuals have a family history of a sibling with Primary Hyperoxaluria,Dent Disease, Cystinuria or APRT Deficiency.\n\nExclusion Criteria:\n\n* Individuals who do not have Primary Hyperoxaluria, Dent Disease, Cystinuria or APRT Deficiency.",{"count":280,"type":21},730,"The purpose of this study is to collect medical information from a large number of patients in many areas of the world with primary hyperoxaluria (PH), Dent disease, Cystinuria and APRT deficiency. This information will create a registry that will help us to compare similarities and differences in patients and their symptoms. The more patients we are able to enter into the registry, the more we will be able to understand the Primary Hyperoxalurias,Dent disease, cystinuria and APRT and learn better ways of caring for patients with these diseases.",[283,120,119,284],"Primary Hyperoxaluria","APRT Deficiency",[128,286,287,288,289,290,291,292,283,293,118,294,119,295,130,296,297,138],"PH1","PH2","PH3","PHI","PHII","PHIII","PH NonI-NonII","Primary Oxalosis","Oxalate","Cystine","Adenine phosphoribosyl transferase deficiency","Dent disease","2026-07-08",{"date":300,"type":38},"2026-07-10",{"date":302,"type":4},"2003-07",{"date":304,"type":21},"2028-06",{"name":150,"class":85},4,{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":18,"minAge":159,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":58,"phases":316,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":336},"100376352","phase-4-controlled-fluid-removal-in-critical-ill-patients-with-fluid-overload-in-the-intensive-care-unit-100376352","NCT04180397","Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.","Goal Directed Fluid Removal With Furosemide in Intensive Care Patients With Fluid Overload - A Randomised, Blinded, Placebo-controlled Trial (GODIF).","GODIF","Inclusion Criteria: ALL below must be met.\n\n* Acute admission to the intensive care unit.\n* Age ≥ 18 years of age\n* Fluid overload ≥ 5% of ideal body weight. If possible, all fluids administered before admission to the intensive care unit are to be included in the calculation of cumulative fluid balance.\n* Clinical stable (minimum criteria: MAP \\> 50 mmHg and maximum infusion of 20 microgram\u002Fkg\u002Fminute of noradrenaline and lactate \\\u003C 4.0 mmol\u002FL)\n\nExclusion Criteria:\n\n* Known allergy to furosemide or sulphonamides.\n* Known pre-hospitalization advanced chronic kidney disease (eGFR \\\u003C 30 mL\u002Fminute\u002F1.73 m\\^2 or chronic RRT).\n* Ongoing renal replacement therapy.\n* Anuria \\> 6 hours.\n* Rhabdomyolysis with indication for forced diuresis\n* Ongoing life-threatening bleeding as these patients need specific fluid\u002Fblood product strategies.\n* Acute burn injury of more than 10% of the body surface area as these patients need a specific fluid strategy.\n* Severe dysnatremia (p-Na \\\u003C 120 or \\> 155 mmol\u002FL) as these patients need a specific fluid strategy.\n* Severe hepatic failure as per the clinical team.\n* Patients undergoing forced treatment.\n* Fertile women (women \\\u003C 50 years) with positive urine human chorionic gonadotropin (hCG) or plasma-hCG.\n* Consent not obtainable as per the model approved for the specific trial site.",{"count":161,"type":21},[317],"PHASE4","This study evaluates the benefits and harms of goal directed fluid removal with furosemide versus placebo in critical ill adult patients with fluid overload in the intensive care unit. Half of the patients will receive furosemide and the other half placebo. The treatment will continue until the excess fluid is excreted.",[320],"Fluid Overload",[322,323,324,325,326],"Fluid overload","Fluid removal","Deresusciation","Diuretics","Fluid accumulation","2026-06-02",{"date":329,"type":38},"2026-06-03",{"date":331,"type":38},"2020-08-17",{"date":333,"type":21},"2028-04-15",{"name":335,"class":85},"Morten H. Bestle",29,{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":18,"minAge":159,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":58,"phases":347,"briefSummary":348,"conditions":349,"keywords":355,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":375},"100549078","phase-4-international-care-bundle-evaluation-in-cerebral-hemorrhage-research-100549078","NCT06429332","International Care Bundle Evaluation in Cerebral Hemorrhage Research","International Care Bundle Evaluation in Cerebral Hemorrhage Research - a Batched Parallel Cluster-randomized Trial With a Baseline Period","I-CATCHER","Inclusion Criteria:\n\n* Adults (age ≥18 years)\n* Non-contrast computerized tomography (NCCT) imaging-verified diagnosis of spontaneous intracerebral haemorrhage\n* ≤24 hours from symptom onset or presumed symptom onset (last seen well)\n\nExclusion Criteria:\n\n* Previous care limitation\n* End-stage comorbidity with short life-expectancy (\\\u003C6 m; e.g. terminal cancer)\n* ICH caused by brain tumor or cerebral venous thrombosis\n* Clinical signs of brain herniation at first presentation (unresponsive patient with bilaterally fixed, maximally dilated pupils)\n* Pregnant women beyond 22 weeks gestation may only be included after thorough discussion with an obstetrician to determine risks vs benefit.",{"count":346,"type":21},3500,[317],"Spontaneous intracerebral haemorrhage (ICH) accounts for approximately 10-15% of all strokes but stands for 50% of stroke-related morbidity and mortality. Approximately half of all patients with ICH have a decreased level of consciousness at hospital admission. Despite this, intensive care and neurosurgical interventions are uncommon. A study conducted in low- and middle-income countries has demonstrated a beneficial effect of a treatment package consisting of early intensive blood pressure lowering, as well as the treatment of pyrexia and elevated blood glucose levels. The I-CATCHER team is now planning to conduct a similar study in Sweden and Australia, as well as in other high-income countries. The study has a clear focus on implementation, aiming to improve treatment and prognosis for patients with ICH within a few years. The purpose of I-CATCHER is to investigate whether a structured treatment package (Care Bundle) improves 3-month prognosis in patients with spontaneous ICH compared to standard care.",[350,351,352,353,354],"Intracerebral Hemorrhage","Intracerebral Haemorrhage","Intraventricular Hemorrhage","Stroke","Cerebrovascular Disease",[356,357,358,359,360,361,362,363,364,365],"intracerebral hemorrhage","oral anticoagulant","blood pressure lowering","early intensive blood pressure lowering","care bundle","implementation study","reversal treatment","outcome","UW-mRS","Modified Rankin Scale","2026-05-20",{"date":368,"type":38},"2026-05-22",{"date":370,"type":38},"2025-01-07",{"date":372,"type":21},"2027-07",{"name":374,"class":85},"Region Skane",54,{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":18,"minAge":383,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":58,"phases":386,"briefSummary":387,"conditions":388,"keywords":393,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":408},"100628708","multimodal-prehabilitation-of-frail-patients-undergoing-elective-knee-or-hip-replacement-100628708","NCT07465159","Multimodal Prehabilitation of Frail Patients Undergoing Elective Knee or Hip Replacement","Multimodal Prehabilitation of Frail Patients 70 Years and Older Undergoing Elective Knee or Hip Replacement: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged 70 years or older assigned to undergo hip\u002Fknee replacement at Landspítali University Hospital.\n* Inclusion will be offered to patients who have previously presented at the outpatient orthopedic department and been scheduled for an elective (with a waiting period ≥2 months before surgery) hip\u002Fknee replacement.\n* Patients who are willing to participate and sign informed consent and are willing to be randomized to the control or intervention arm.\n\nExclusion Criteria:\n\n* Patients who screen negative for all frailty tools will be excluded from the study.\n* Patients who are already in active physiotherapy, meeting with a physiotherapist \\>1 every month, will also be excluded.\n* In addition, those who do not undergo planned surgery, are undergoing redo hip\u002Fknee prosthesis replacement will be excluded","70 Years",{"count":385,"type":21},50,[163],"Background: Frailty is a geriatric syndrome of reduced physiologic reserve that increases surgical risk and is common among older adults undergoing hip or knee replacement. While prehabilitation has shown promise in enhancing outcomes, evidence from randomized controlled trials (RCTs) in frail orthopedic patients is limited.\n\nObjective: This study aims to evaluate the feasibility and preliminary data on the effectiveness of a multimodal prehabilitation program for frail patients undergoing elective hip or knee arthroplasty.\n\nMethods: A pilot RCT will be conducted at Landspítali-University Hospital. Patients ≥70 years scheduled for surgery with ≥2 months waiting time will be screened for frailty using PRISMA-7, the Clock Drawing Test, and Timed Up \\& Go. Patients screening positive for any of the three screening tools will be randomized to multimodal prehabilitation or standard of care. The intervention includes comprehensive geriatric assessment, medication review, tailored physiotherapy using the Otago Exercise Programme, and nutritional counseling if at risk of malnutrition. We will conduct an external pilot for feasibility measures (overall enrollment, recruitment, retention, adherence). Secondary outcomes include physical performance, postoperative complications, patient-reported health status (WOMAC scale) and quality of life (EQ-5D-5L ), length of primary hospital stay, discharge location, falls postoperatively, 180-day readmission and 180-day mortality.\n\nSignificance: This trial may aid in the design of larger RCT study and provide a signal of the role of multimodal prehabilitation on outcomes, including quality of life and health status among frail arthroplasty patients.",[389,390,391,392],"Frailty Syndrome","Prehabilitation","Arthroplasties, Knee Replacement","Arthroplasties, Hip Replacement",[394,395,390,396,397,398],"Frailty","Arthroplasty","Multimodal prehabilitation","Knee replacement","Hip replacement","2026-04-01",{"date":401,"type":38},"2026-04-07",{"date":403,"type":38},"2026-03-20",{"date":405,"type":21},"2027-12-31",{"name":407,"class":85},"University of Iceland",1,{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":18,"minAge":417,"maxAge":159,"enrollmentInfo":418,"targetDuration":4,"studyType":58,"phases":420,"briefSummary":421,"conditions":422,"keywords":424,"overallStatus":429,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":408},"100628723","ocd-summer-treatment-program-for-adolescents-in-iceland-100628723","NCT07465354","OCD Summer Treatment Program for Adolescents in Iceland","Intensive OCD Summer Treatment Program for 12-18-year-old Adolescents in Iceland","OCDtreatment","Inclusion Criteria:\n\n* OCD diagnosis\n* Adolescents are fluent in Icelandic\n* Parents are fluent in Icelandic or English\n\nExclusion Criteria:\n\n* Intellectual disability\n* Severe suicidal ideation\n* Acute psychiatric disorders requiring immediate intervention, e.g. schizophrenia\n* Severely impairing levels of autism prohibiting group participation","12 Years",{"count":419,"type":21},70,[163],"The aim of the study is to examine the effectiveness of OCD treatment delivered in a group format for adolescents during a two week intensive summer treatment program.",[423],"Obsessive-Compulsive Disorder (OCD)",[425,426,427,428],"Obsessive-compulsive disorder","Adolescents","intensive cognitive-behavioral treatment","Exposure and response prevention","NOT_YET_RECRUITING","2026-03-17",{"date":432,"type":38},"2026-03-18",{"date":434,"type":21},"2026-05-01",{"date":436,"type":21},"2033-09-01",{"name":407,"class":85},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":252,"sex":18,"minAge":383,"maxAge":4,"enrollmentInfo":445,"targetDuration":447,"studyType":22,"phases":4,"briefSummary":448,"conditions":449,"keywords":454,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":408},"100627717","modified-essential-frailty-toolset-in-older-adults-undergoing-major-elective-surgery-100627717","NCT07452263","Modified Essential Frailty Toolset in Older Adults Undergoing Major Elective Surgery","Modified Essential Frailty Toolset for Predicting Postoperative Complications and Readmission in Older Adults Undergoing Major Elective Surgery","Inclusion Criteria:\n\n* Patients ≥ 70 years who present for preoperative work-up at the admissions department at Landspitali and undergo frailty screening.\n* Patients assigned to undergo major surgery\n\nExclusion Criteria:\n\n* Cardiac surgery\n* Not undergoing planned surgery",{"count":446,"type":21},250,"6 Months","Frailty is a common geriatric syndrome associated with reduced physiological reserve and increased vulnerability to surgical stress. As the population ages, more older adults undergo major elective surgery, yet frailty is often insufficiently assessed in routine practice and no universally accepted screening tool exists.\n\nThe Essential Frailty Toolset (EFT) is a simple validated frailty assessments and has demonstrated strong predictive value for mortality and major postoperative complications, particularly in cardiac surgery populations. EFT incorporates four key domains of cognition, anemia, serum albumin, and physical function capturing both physical and cognitive vulnerability. A modified version (mEFT) has been developed to improve feasibility and applicability in broader surgical settings, requiring minimal training and only a few minutes to administer. Despite its promise, mEFT has not been evaluated in elderly patients undergoing major elective non-cardiac surgery, representing an important gap in the current literature and motivating the present study.\n\nWe therefore propose a modified and simplified frailty screening tool tailored for elderly patients undergoing major elective non-cardiac surgery at our institution. The modified Essential Frailty Toolset (mEFT) is a multi-dimensional assessment designed to address this gap by evaluating physical function, cognition, nutrition, and anemia in just a few minutes. In this version, the tool assigns points based on specific clinical markers: the Timed Up and Go (TUG) test provides one point for a time ≥11.0 seconds and two points for ≥15.0 seconds; the Clock Drawing Test (CDT) provides one point for a score of ≤2 on a 3-point scale; nutritional risk is captured with one point for a BMI \\\u003C22.0 or unintentional weight loss of 5% over the last six months; and anemia provides one point based on hemoglobin levels (below 130g\u002FL for men and 120 g\u002FL for women). These modifications were made to enhance feasibility and clinical relevance in our population. Low serum albumin was rare in our cohort and therefore demonstrated limited discriminatory value as a screening marker. In contrast, low BMI and recent weight loss are well-established risk factors for malnutrition and sarcopenia and are readily obtainable in routine preoperative assessment. Similarly, both the TUG and CDT are quick, inexpensive, and require minimal training, making them well suited for large-scale screening in preoperative clinics.Importantly, the proposed components have been evaluated in a pilot study conducted in our institution.\n\nThis study will evaluate whether a high mEFT score (≥3) is associated with increased postoperative complications and 90-day readmissions among patients aged ≥70 years undergoing major elective surgery. Patients presenting for admission will be included. If mEFT accurately identifies high-risk patients, it may improve preoperative risk stratification, inform shared decision-making, and help identify individuals who could benefit from targeted prehabilitation, supporting broader implementation of frailty screening in surgical care.",[450,389,451,452,453],"Frailty in Adult Surgery","Elective Surgeries","Readmission Rates","Postoperative Complication",[394,455,456,457,458,459],"Postoperative Outcomes","Major elective surgery","Surgical Frailty","Readmission","Complications","2026-03-06",{"date":462,"type":38},"2026-03-10",{"date":464,"type":38},"2025-01-20",{"date":466,"type":21},"2026-12-31",{"name":407,"class":85},{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":252,"sex":18,"minAge":159,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":58,"phases":476,"briefSummary":477,"conditions":478,"keywords":482,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":493,"locationsCount":495},"100606450","evaluating-methods-to-replicate-stumbles-and-slips-during-walking-100606450","NCT07175714","Evaluating Methods to Replicate Stumbles and Slips During Walking","Inclusion Criteria:\n\n* 40 kg \\\u003C body weight \\\u003C 136kg\n* Cognitive ability to understand all instructions and questionnaires in the study\n* Willing and able to participate in the study and following the protocol\n* Age ≥ 18 years\n* Able to walk independently without the use of assistive device such as a cane or walker\n* Able-bodied subjects OR Regular prosthesis users for at least 1 year with unilateral lower limb amputation at or below the transfemoral level (or equivalent level limb deficiency)\n\nExclusion Criteria:\n\n* Subjects with pain which can affect their mobility\n* Users with socket comfort score less than 7\n* Subjects with cognitive impairment\n* Pregnant subjects\n* Musculoskeletal disorders or neurological conditions that affect motor function, gait or balance\n* Use of medications that are known to impair balance and coordination\n* Any other conditions deemed by the investigator to make participation unsafe",{"count":475,"type":21},20,[163],"This protocol outlines a study designed to investigate three different methodologies for inducing gait perturbations.\n\nSubjects will be divided into two groups: prosthetic users and able-bodied individuals.\n\nEach group will undergo a series of tests where controlled perturbations are applied using up to three methodologies with the number depending on factors such as time and fatigue. These methodologies may include mechanical, visual, or auditory perturbations designed to mimic unexpected obstacles or changes in terrain.",[479,480,481],"Fall Prevention","Balance, Falls","Amputation of Lower Limb",[483,484,485,486],"amputation","falls","fall prevention","balance","2026-02-10",{"date":489,"type":38},"2026-02-13",{"date":491,"type":38},"2025-05-26",{"date":466,"type":21},{"name":494,"class":45},"Össur Iceland ehf",2,{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":18,"minAge":159,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":58,"phases":504,"briefSummary":507,"conditions":508,"keywords":511,"overallStatus":429,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":528},"100624318","phase-1-sodium-bicarbonate-as-an-alternative-to-potassium-citrate-for-kidney-stones-100624318","NCT07408076","Sodium Bicarbonate as an Alternative to Potassium Citrate for Kidney Stones","Inclusion Criteria:\n\n* Adult \\>18 years of age\n* History of nephrolithiasis\n* One 24h urine collections within one year of enrollment with hypocitraturia.\n* Patients currently utilizing or considering use of Kcit for stone prevention\n\nExclusion Criteria:\n\n* Individuals with known metabolic disorders\n* Individuals with other known causes of nephrolithiasis\n* Anyone who, in the opinion of the PI, is unfit or unsuitable to participate in the study",{"count":503,"type":21},30,[505,506],"PHASE1","PHASE2","Kidney stones affect 1 in every 11 people in the US each year. In patients with kidney stones who are prescribed medications for stone management, only 30.2% are adherent to a medication regime and even fewer, only 13.4 % are adherent with citrate medications.\n\nPrescription potassium citrate can be expensive for many patients, leading to non-compliance. Sodium bicarbonate is a potential medication alternative that is cheaper and can potentially alkalinize the urine and\u002For decrease the risk of future kidney stones. However, efficacy of alternatives to potassium potassium citrate are not well studied.\n\nThis study seeks to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of patients with kidney stones and compare this to prescription potassium citrate.",[509,510],"Kidney Stones, Urolithiasis, Hypocitraturia","Nephrolithiasis",[512,513,514,515,516,517,518],"kidney stone","stone","calcium oxalate","calcium phosphate","potassium citrate","sodium bicarbonate","nephrolithiasis","2026-02-05",{"date":521,"type":38},"2026-02-12",{"date":523,"type":21},"2026-02-01",{"date":525,"type":21},"2028-02-01",{"name":527,"class":85},"University of California, Los Angeles",6,{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":252,"sex":18,"minAge":383,"maxAge":4,"enrollmentInfo":536,"targetDuration":538,"studyType":22,"phases":4,"briefSummary":539,"conditions":540,"keywords":542,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":548,"leadSponsor":550,"locationsCount":408},"100621223","validity-of-frailty-screening-tools-as-a-measure-for-postoperative-outcomes-100621223","NCT07367828","Validity of Frailty Screening Tools as a Measure for Postoperative Outcomes","Feasibility and Validity of Frailty Screening Tools as a Measure of Postoperative Outcomes in Older Patients Undergoing Elective Surgery","Inclusion Criteria:\n\n* Patients ≥ 70 years who present for preoperative work-up at the anesthesia department at Landspitali.\n* Patients assigned to undergo intermediate\u002Fmajor surgery\n\nExclusion Criteria:\n\n* Not undergoing planned surgery",{"count":537,"type":21},350,"1 Year","Frailty is a common geriatric syndrome defined as a clinical state of decreased physiologic reserve resulting in increased vulnerability to stressors. It is associated with several unfavorable postoperative complications independent of age such as readmission, length of hospital stay and mortality. To address these concerns, medical societies have acknowledged a need for routine screening to identify elderly patients who are at high risk for major complications before undergoing surgery.\n\nIn the absence of a golden standard for frailty assessment, there are multiple assessment tools available. However, the challenge with many frailty tools is that they can be time-consuming, and require expertise and clinical training.This poses a challenge for screening a large elderly population before surgery. Some frailty assessment tools, such as PRISMA7 (The Program of Research to Integrate Services for the Maintenance of Autonomy), timed up and go (TUG) and the clock drawing test (CDT), have been demonstrated to be quick, simple and easy to use with minimal training.\n\nThe PRISMA-7 is a frailty screening questionnaire that consists of seven dichotomous items considering age, gender, health problems that affect activities of daily living (ADLs), assistance from others with ADLs, having to count on someone if needed, and the use of mobility aids.\n\nThe TUG test is used for assessing fall risk and frailty in older patients. It is measured by the time it takes an individual to stand up from a seated position, walk three meters and return back to a seated position. There is no standard cut-off for TUG, however, a cut-off of \\> 10 seconds has been used to identify frailty.\n\nCognitive impairment in older surgical patients may predispose patients to executive dysfunction that many elderly patients experience postoperatively and has shown to be a risk factor for surgical complications. Some studies suggest a strong relationship between cognitive impairment and physical frailty resulting in cognitive frailty when evaluating older adults.The CDT has shown to be a valuable screening tool for cognitive concerns. When administering the CDT, a patient receives instructions to draw a clock. Performing the test requires auditory comprehension, planning, sustained attention, visual-spatial skills and executive skills.\n\nThe prevalence of surgical frailty in Iceland has not been researched thoroughly enough to provide an accurate estimate. This is important to reveal the number of senior surgical patients at high risk of adverse postoperative outcomes who could benefit from a preoperative intervention. However, there is a lack of consensus on an optimal frailty assessment to screen patients for identifying frail patients prior to surgery, and more research is needed to evaluate which group of patients would benefit the most from prehabilitation.\n\nThe scientific value of this study is to elucidate the extent of frailty risk and its associated postoperative outcomes in older surgical patients undergoing elective surgery. We opt to find a convenient screening routine prior to surgery to identify patients at risk of frailty. Therefore, the study aims to validate three frailty screening methods and to assess a positive screening result as an independent risk factor for adverse postoperative outcomes in a cohort of elderly surgical patients undergoing elective surgery. We hypothesize that elderly patients at risk of frailty have a higher rate of surgical complications than patients not at risk of frailty.\n\nPatients aged ≥ 70 years who undergo elective surgery will be prospectively examined at the Department of Anesthesiology and Critical Care of Landspítali. The screening assessments to be evaluated are the Program of Research to Integrate Services for the Maintenance of Autonomy (PRISMA-7), a combination of Timed Up \\& Go (TUG), Clock Drawing Test (CDT) and the FRAIL questionnaire, and a combination of PRISMA-7, TUG and CDT. Additional clinical data and outcomes will be obtained from the electronic medical records of Landspítali. The postoperative outcomes measured will be 180-day mortality, surgical complications, 90-day readmission, delirium, non-home discharge and length of hospital stay.\n\nPatients who screen positive on the CDT (≤ 2\u002F3 points) and TUG (≥ 11 seconds) will be considered frail. Those who do not screen positive on both of these tests will be part of the control group (non-frail).",[450,389,541],"Elective Surgery",[394,455,456,457,543],"Intermediate elective surgery","2026-01-19",{"date":546,"type":38},"2026-01-26",{"date":464,"type":38},{"date":549,"type":21},"2026-12-21",{"name":407,"class":85},{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":18,"minAge":159,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":58,"phases":560,"briefSummary":561,"conditions":562,"keywords":564,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":577},"100576175","phase-4-chemoablation-or-bladder-resection-with-adjuvant-chemotherapy-in-recurrent-non-muscle-invasive-bladder-cancer-100576175","NCT06781879","Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer","COBRA-NMIBC","Inclusion Criteria:\n\n* Tumour recurrence after previous urothelial tumour of Ta low-grade\n* Tumours smaller than 2 cm in diameter\n* Negative urine cytology (optional)\n* ≥18 years of age\n* Ability to understand and comprehend the provided written and oral information\n* Has provided written consent\n\nExclusion Criteria:\n\n* Known history of invasive tumour of the bladder (T1+)\n* Known history of CIS of the bladder\n* Previous MMC or BCG-treatment except for single instillations following previous TURBTs\n* Known allergy or intolerance to MMC\n* Solid tumour with suspicions of invasion\n* Tumour in the bladder neck or urethra\n* Suspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious flat lesions seen at cystoscopy)\n* Small bladder volume (less than 100 ml) or incontinence\n* Prior radiation therapy to the pelvic area, as radiation affects the bladder function and instillation therapy is a suboptimal treatment for this patient group\n* Acute cystitis\n* Pregnancy or breast-feeding\n* Averse to using secure contraception with regard to men with partners and premenopausal women",{"count":559,"type":21},272,[317],"The investigartors will conduct a randomized, multinational study with the aim to assess if the efficacy of a dose dense chemoablation with Mitomycin C (MMC) with adjuvant BCG in non-responding patients is superior regarding long term effect compared to standard treatment with trans urethral resection of bladder tumors (TURBT) and adjuvant intravesical instillation therapy in patients with recurrent Ta LG tumors.\n\nThe study is a natural follow-up study following the pivotal NICSA trial supported by the Danish Cancer Society that has lead to the initial change in the European guidelines. In order to not only be comparable to current standard, but also to improve clinical outcome and furthermore confirm the previous findings, the investigators here suggest to implement at patient tailored approach through a new multicenter RCT.\n\nThe investigators hypothesize that chemoablation with MMC in patients with recurrent Ta LG tumors will result in a permanent low recurrence rate in patients with complete response, whereas patients without complete response can be selected for adjuvant BCG which theoretically is more efficient in this select patient group. This will potentially result in a more favorable long term recurrence free survival (RFS) rate compared to the current standard regimen where all patients are treated with TURBT and adjuvant instillation therapy.\n\nThe incidence of bladder cancer in Denmark is almost 2,000 per year. Of these, 75% have non-muscle invasive bladder cancer (NMIBC). The yearly recurrence rate of NMIBC is approximately 35% and the disease is therefore one of the most costly cancers to manage on a per patient basis, due to the cost of operative procedures, follow-up cystoscopies and instillation therapies",[563],"Non-Muscle Invasive Bladder Cancer",[565,566,567],"Recurrence","Ta low.grade","Chemoablation","2025-09-30",{"date":570,"type":38},"2025-10-03",{"date":572,"type":38},"2025-06-01",{"date":574,"type":21},"2032-02-01",{"name":576,"class":85},"Jakob Kristian Jakobsen",8,{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":584,"eligibilityCriteria":585,"healthyVolunteers":252,"sex":586,"minAge":159,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":58,"phases":589,"briefSummary":590,"conditions":591,"keywords":4,"overallStatus":429,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":408},"100592402","evaluation-of-the-scar-healing-effects-of-chitocare-medical-scar-healing-gel-in-women-undergoing-breast-reduction-or-mastopexy-surgery-chitoscar-100592402","NCT06992960","Evaluation of the Scar Healing Effects of ChitoCare Medical Scar Healing Gel in Women Undergoing Breast Reduction or Mastopexy Surgery (CHITOSCAR)","A Prospective, Randomised, Split-Body, Controlled, Non-Inferiority Clinical Study on the Scar Healing Effects of ChitoCare Medical Scar Healing Gel in Women Undergoing Breast Reduction or Mastopexy Surgery (CHITOSCAR)","CHITOSCAR","Inclusion Criteria:\n\n* Written informed consent must be given\n* Female ≥ 18 years old\n* Having planned or very recently (within 21 days) undergone breast reduction or mastopexy surgery on both breasts\n* Not yet begun any treatment aimed at reducing scarring\n* Wound is not infected at the time of enrolment\n* Able to understand and comply with the requirements of the study\n\nExclusion Criteria:\n\n* Patients with serious concomitant disease (cancer, heart failure (NYHA class IV), severe anaemia (Hb\\\u003C100 g\u002FL), neoplasia)\n* Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness)\n* Patients who will require additional surgical procedures during the study\n* Patients diagnosed with autoimmune connective tissue diseases\n* Previous treatment under this clinical protocol\n* Participation in another clinical trial\n* Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, is known to interfere with, or affect the rate and quality of wound healing\n* Allergy to shellfish\\* (if unknown, the patient may try a small sample of the IP on their intact skin to assess for any potential allergic reaction.)\n* Medical condition likely to require systemic corticosteroids during the study period\n* Pregnant or lactating women\n* Smoker","FEMALE",{"count":588,"type":21},39,[163],"Patients undergoing breast reduction or mastopexy surgery will be screened and recruited for participation in the study. Eligible patients will act as their own control with one breast receiving the active intervention (ChitoCare® medical Scar Healing Gel) and the other receiving standard of care (Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch). The active and control interventions will be applied for six months, and participants will be followed for up to 12 months. The scar properties of each breast will be assessed at study initiation (Day 0) and at study visits at 3, 6, 9, and 12 months using the Patient and Observer Scar Assessment Scale (POSAS) and via blinded assessment of photographs. Other subjective parameters such as pain, itching, and overall perception of the healed wound will be collected at each study visit via the POSAS, and patients' opinion, preferences, and compliance regarding the treatments will be collected via a basic questionnaire.",[592],"Surgical Scars","2025-08-13",{"date":595,"type":38},"2025-08-14",{"date":597,"type":21},"2025-09",{"date":599,"type":21},"2026-10",{"name":601,"class":45},"Primex ehf",{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":18,"minAge":159,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":58,"phases":611,"briefSummary":612,"conditions":613,"keywords":615,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":623,"locationsCount":625},"100455824","scandinavian-trial-of-uncomplicated-aortic-dissection-therapy-100455824","NCT05215587","Scandinavian Trial of Uncomplicated Aortic Dissection Therapy","SUNDAY","Inclusion Criteria:\n\nAll subjects, aged 18 or greater at the time of informed consent, admitted or referred to the participating vascular surgery site with an uTBAD of less than four weeks duration.\n\nExclusion Criteria:\n\n* Subjects with no signed informed consent.\n* Subjects presenting with a complicated type B aortic dissection according to the above definition.\n* Subjects previously treated in their descending aorta, either open surgery or TEVAR.\n* Subjects with pre-existing thoracoabdominal aortic aneurysm.\n* Subjects with other aortic pathology with an indication for intervention that requires TEVAR.\n* Subjects with traumatic aortic dissections.\n* Subjects with an established connective tissue disease at the time of randomization, including but not limited to Marfans and Loeys-Dietz syndrome.\n* Subjects with a clinically estimated life expectancy \\\u003C 2 years.\n* Subjects with dementia.\n* Pregnant or nursing subjects.\n* Subjects with current sepsis.\n* Subjects currently participating in other clinical interventional trials.",{"count":610,"type":21},554,[163],"The introduction of thoracic endovascular aortic repair (TEVAR) in 1994 has radically changed the treatment of thoracic aortic pathology, and TEVAR is now the recommended therapy for \"complicated\" TBADs and other thoracic aorta diseases. To date, the use of TEVAR in the treatment of \"uncomplicated\" dissections (uTBAD) is uncertain, although it is presumed that a prophylactic procedure can prevent later complex surgery and early death. Several analyses have found that TEVAR confers improved aortic remodeling and possibly survival, although these were underpowered for this specific outcome. In addition, there are several reports regarding the uncertain benefit or harm of this intervention in the vascular surgery community. Put another way, there is equipoise, and the need for robust evidence in the form of a randomized clinical trial has been clearly iterated by the European Society of Vascular Surgery.\n\nThis randomized, open-label, two-armed controlled study directly addresses this question of whether TEVAR alters 5-year survival among patients with an uTBAD. Patients will be randomized to either standard medical therapy (SMT) alone or TEVAR in addition to SMT. The primary outcome is 5-year survival, while secondary outcomes include aortic-related mortality, neurological events, quality of life, costs, re interventions and readmissions. in addition, subgroup analyses based on the extent of treatment.\n\nSample size calculations based on previous reports indicate the need to include approximately 554 patients. Patients will be recruited from multiple centres in Scandinavia. Based on the population (24 million) and incidence of uTBAD (approximately 480 per year), and depending on the total number of participating centres, a conservative estimate of two to three years is required for enrolment.",[614],"Aortic Dissection",[616],"Aortic; dissection; TEVAR; endovascular; vascular","2025-08-08",{"date":619,"type":38},"2025-08-11",{"date":621,"type":38},"2023-05-24",{"date":267,"type":21},{"name":624,"class":85},"University of Aarhus",28,{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":586,"minAge":159,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":58,"phases":635,"briefSummary":636,"conditions":637,"keywords":640,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":408},"100592132","digital-patient-support-program-for-self-efficacy-and-medication-adherence-in-women-on-adjuvant-endocrine-treatment-for-breast-cancer-100592132","NCT06989450","Digital Patient Support Program for Self-efficacy and Medication Adherence in Women on Adjuvant Endocrine Treatment for Breast Cancer","Digital Patient Support Program for Self-Efficacy and Medication Adherence Amongst Women on Adjuvant Endocrine Treatment for Breast Cancer: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult patient (18 years or older) diagnosed with breast cancer of stage I, II or III from 1st September 2023 or later\n* Have been prescribed adjuvant endocrine therapy for breast cancer.\n* Understands written and spoken Icelandic or English.\n* Owns a smart-phone compatible with the Sidekick app and capable to use it\n* Willing to download the Sidekick app on the smart-phone and to comply with the study measures and visits according to the protocol.\n* Capable of providing informed consent for participating in the study.\n\nExclusion Criteria:\n\n* Having other concurrent conditions that in the opinion of the oncologist may compromise patient safety or study objectives.\n* Concurrent participation in another clinical study in which the study treatment may confound the evaluation of the investigational program.\n* Metastatic breast cancer (stage IV)\n* Previous experience with Sidekick breast cancer program",{"count":634,"type":21},140,[163],"This is a randomized, controlled study to assess the effect of Sidekick Health's digital program on self-efficacy and medication adherence in breast cancer patients prescribed adjuvant anti-hormonal treatment. Participants will be treated with the digital program in addition to standard of care (SoC), or SoC only.",[638,639],"Breast Cancer","Cancer",[639,638,641,642,643,644,645],"Medication adherence","self-efficacy","lifestyle change","endocrine treatment","digital health application","2025-05-16",{"date":648,"type":38},"2025-05-25",{"date":650,"type":21},"2025-05-31",{"date":652,"type":21},"2026-12-30",{"name":654,"class":45},"Sidekick Health",{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":18,"minAge":159,"maxAge":4,"enrollmentInfo":662,"targetDuration":4,"studyType":58,"phases":664,"briefSummary":665,"conditions":666,"keywords":668,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":673,"lastUpdatePostDateStruct":674,"startDateStruct":676,"completionDateStruct":678,"leadSponsor":680,"locationsCount":408},"100517851","behavioural-activation-for-bipolar-depression-100517851","NCT06022913","Behavioural Activation for Bipolar Depression","Adjunctive Behavioural Activation for Bipolar Depression: A Case Series (BA-BD)","Inclusion Criteria:\n\n* scoring in the clinical range on a self-report measure of depression severity (the PHQ-9) meeting diagnostic criteria for depression based on a diagnosis on Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)\n\nmeeting diagnostic criteria for Bipolar I or II Disorder DIAMOND) participants will require a working knowledge of written and spoken Icelandic, sufficient to make use of therapy and complete research assessments without the need for a translator.\n\nExclusion Criteria:\n\n* current\u002Fpast learning disability, organic brain change, substance dependence (drugs and alcohol) that would compromise the ability to use therapy\n* current marked risk to self (i.e., self-harm or suicide) that we deem could not be appropriately managed in the Bipolar outpatient clinic at Landspitali.\n* currently lacking the capacity to give informed consent\n* currently receiving other psychosocial therapy for depression or bipolar disorder\n* presence of another area of difficulty that the therapist and client believe should be the primary focus of intervention (for example, Post-Traumatic Stress Disorder, psychosis)",{"count":663,"type":21},10,[163],"Bipolar disorder (BD) affects between 1-3% of the world's population. People with BD experience episodes of mania or hypomania and in most cases, they experience periods of depression which can cause difficulties in daily life. Psychological therapies for people experiencing depression without mania or hypomania are widely available, but there is little research into how effective these therapies are for people with BD. Behavioral activation therapy (BA) is based on behavioral theory and has been proven to be an effective treatment for unipolar depression. It helps people re-establish healthier activity patterns and sleep regulation, especially in BD for mood stabilization. BA is theoretically and clinically well matched to the treatment of bipolar depression, but there is still very little research into offering BA to people with BD.\n\nThe first aim of the current research is to implement BA for people with depression in Bipolar Disorder and study if it is feasible for this patient group. The second aim is to do a pilot study on the effectiveness of the treatment for this patient group. The research will be implemented with people seeking treatment at the specialized service for bipolar disorder at Landspítali University Hospital in Iceland. The participants will receive treatment as usual and the BA will be adjunctive.\n\nAt least ten people, that are currently experiencing Bipolar Depression and are willing to take part, will receive up to 20 individual therapy sessions of BA that have been adapted for Bipolar Depression (BA-BD), and will complete regular questionnaires and interviews.\n\nThe study will be a replication study to validate the previous study's findings by Kim, W. et al., 2022 in another setting.",[667],"Bipolar Depression",[669,670,671,672],"Bipolar depression","Bipolar Disorder","Behavioural Activation","Depression","2025-04-11",{"date":675,"type":38},"2025-04-16",{"date":677,"type":38},"2023-11-22",{"date":679,"type":21},"2025-12-31",{"name":681,"class":85},"Reykjavik University",{"id":683,"slug":684,"hasResults":12,"nctId":685,"briefTitle":686,"officialTitle":687,"acronym":688,"eligibilityCriteria":689,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":690,"enrollmentInfo":691,"targetDuration":4,"studyType":58,"phases":693,"briefSummary":694,"conditions":695,"keywords":698,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":702,"lastUpdatePostDateStruct":703,"startDateStruct":705,"completionDateStruct":707,"leadSponsor":708,"locationsCount":710},"100511706","the-neu-stim-trial-100511706","NCT05942924","The NEU-STIM Trial","A Randomised Trial of Repetitive Versus Selective Tactile Stimulation for Preterm Infants at Birth: The NEU-STIM Trial","NEU-STIM","Inclusion Criteria:\n\n* Infants born before 32 weeks of gestation can be included in this trial after parental consent.\n\nExclusion Criteria:\n\n* Infants will be excluded if they are found to have a congenital abnormality or condition that has an adverse effect on breathing\u002Fventilation or oxygenation, including: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease and surfactant protein deficiency. Many of the infants enrolled in the study will later be diagnosed with respiratory distress syndrome (RDS); this will not render them ineligible for inclusion.","32 Weeks",{"count":692,"type":21},3280,[163],"The aim of this study is to determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth. Infants born before 32 weeks of gestation will be included in this trial. This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioral aspect - in this case the performance of tactile stimulation.",[696,697],"Infant, Premature, Diseases","Birth, Preterm",[699,700,701],"Preterm infant","Tactile stimulation","Resuscitation","2025-03-05",{"date":704,"type":38},"2025-03-10",{"date":706,"type":38},"2024-03-11",{"date":679,"type":21},{"name":709,"class":85},"Leiden University Medical Center",43,{"id":712,"slug":713,"hasResults":12,"nctId":714,"briefTitle":715,"officialTitle":715,"acronym":716,"eligibilityCriteria":717,"healthyVolunteers":12,"sex":18,"minAge":159,"maxAge":4,"enrollmentInfo":718,"targetDuration":4,"studyType":58,"phases":720,"briefSummary":721,"conditions":722,"keywords":730,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":737,"lastUpdatePostDateStruct":738,"startDateStruct":740,"completionDateStruct":742,"leadSponsor":744,"locationsCount":747},"100491430","phase-3-stroke-prophylaxis-with-apixaban-in-chronic-kidney-disease-stage-5-patients-with-atrial-fibrillation-100491430","NCT05679024","Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation","SACK","Inclusion Criteria:\n\n1. Signed Written Informed Consent\n2. 18 years of age or older\n3. Ongoing treatment with any chronic dialysis treatment OR an estimated glomerular filtration rate (eGFR)\\* \\\u003C20 ml\u002Fmin\u002F1.73 m2 at least twice 3 months apart of which at least one occasion is \\\u003C15 ml\u002Fmin\u002F1.73 m2 due to CKD during the last year (12 months).\n4. Diagnosis of chronic (i.e., repeated) paroxysmal, persistent, or permanent atrial fibrillation (AF) or atrial flutter (AFL)\n5. CHA2DS2-VASc score ≥2 or more for men ≥3 or more for women as an indication for oral anticoagulation\n6. Women of childbearing potential (WOCBP) should have a negative highly effective pregnancy test at screening and must agree to follow instructions for method(s) of contraception for the duration of treatment\n\nExclusion Criteria:\n\nParticipants may not be included in the study if any of the following criteria are met:\n\n1. AF or AFL due to reversible causes (e.g., thyrotoxicosis, pericarditis)\n2. Any degree of rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study\n3. Any condition other than AF or AFL that requires chronic anticoagulation (e.g., a prosthetic mechanical heart valve, antiphospholipid syndrome).\n4. Any contraindication for anticoagulation including\n\n   1. endocarditis\n   2. documented intolerance for apixaban\n   3. liver disease with documented coagulation disorder\n   4. pregnancy or breast feeding\n5. Active bleeding or serious bleeding within 3 months, or\n\n   1. documented hemorrhagic blood dyscrasia\n   2. patients currently receiving dual antiplatelet therapy\n6. Planned for surgery\n\n   1. kidney transplantation with a living donor within 3 months\n   2. active on the kidney transplant waiting list at a kidney transplant center where apixaban use is prohibited\n   3. valvular heart disease surgery\n7. Current use of strong inhibitors of both CYP3A4 and P-glycoprotein in accordance with the summary of product characteristics (SmPC) of apixaban or regular intake of non-steroidal anti-inflammatory drugs (NSAID) or cyclooxygenase-2 (COX2) inhibitors\n8. Any condition or circumstance in which the patient should not participate in the study according to the study investigator (reason documented in the pre-screening protocol)\n\nBeing active on the kidney transplant waiting list is not an exclusion criterion if it is allowed according to the current clinical guidelines at the transplant clinic where the patient is registered. The patient must report changes in waiting list status to the investigator promptly.",{"count":719,"type":21},1400,[60],"Objective: To study the efficacy and safety of apixaban as stroke prophylaxis in patients with chronic kidney disease (CKD) stage 5 and atrial fibrillation (AF) with or without dialysis treatment. The study hypothesis is that compared to no anticoagulation, apixaban reduces the incidence of ischemic stroke without causing an unacceptable increase in fatal or intracranial bleeding events.\n\nThe secondary objectives are to evaluate the risk of all-cause mortality, cardiovascular events, and major bleeding in people with CKD stage 5 and AF treated with apixaban compared to standard of care without anticoagulation.\n\nTrial design: Pragmatic Prospective Open Label Randomized Controlled Clinical Trial, phase 3b over 12-72 months.\n\nTrial population: 1000-1400 patients at ≈50 sites in Sweden, Finland, Norway, Iceland and Poland Eligibility criteria: Adults ≥18 years with CKD stage 5 (ongoing treatment with any chronic dialysis treatment OR an estimated glomerular filtration rate (eGFR)\\* \\\u003C20 ml\u002Fmin\u002F1.73 m2 at least twice 3 months apart of which at least one occasion is \\\u003C15 ml\u002Fmin\u002F1.73 m2 due to CKD during the last 12 months) and a diagnosis of chronic, paroxysmal, persistent, or permanent AF or atrial flutter (AFL) with CHA2DS2-VASc score ≥2 for men or ≥3 or more for women as an indication for oral anticoagulation.\n\nThe exclusion criteria are AF or AFL due to reversible causes, rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study, a condition other than AF or AFL that requires chronic anticoagulation, contraindications for anticoagulation, active bleeding or serious bleeding within 3 months, planned for surgery within 3 months, and current use of strong inhibitors of both CYP3A4 and P-glycoprotein.\n\nInterventions: Randomization 1:1 to treatment with apixaban 2.5 mg twice daily and standard of care, or standard of care and no anticoagulation.\n\nOutcome measures: primary efficacy (time to first ischemic stroke); primary safety (the composite of time to first intracranial bleeding or fatal bleeding); secondary efficacy (time to all-cause mortality, time to cardiovascular event or cardiovascular death); secondary safety (time to first major bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria)",[723,724,353,350,725,726,727,728,729],"Chronic Kidney Diseases","Atrial Fibrillation","Major Bleed","Cardiovascular Complication","Death","Kidney Transplant; Complications","Thromboses, Venous",[731,732,733,734,735,736],"Chronic kidney disease","Hemodialysis","Peritoneal dialysis","Kidney transplantation","Atrial fibrillation","Oral anticoagulation","2024-10-02",{"date":739,"type":38},"2024-10-04",{"date":741,"type":38},"2023-02-17",{"date":743,"type":21},"2028-12-31",{"name":745,"class":746},"Region Stockholm","OTHER_GOV",34,{"id":749,"slug":750,"hasResults":12,"nctId":751,"briefTitle":752,"officialTitle":753,"acronym":754,"eligibilityCriteria":755,"healthyVolunteers":12,"sex":18,"minAge":756,"maxAge":757,"enrollmentInfo":758,"targetDuration":4,"studyType":58,"phases":760,"briefSummary":761,"conditions":762,"keywords":770,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":774,"lastUpdatePostDateStruct":775,"startDateStruct":777,"completionDateStruct":779,"leadSponsor":781,"locationsCount":408},"100562203","effect-of-educational-intervention-on-childrens-anxiety-100562203","NCT06600113","Effect of Educational Intervention on Children's Anxiety","Evaluating Effectiveness of Different Educational Methods on the Anxiety of Children Undergoing Anaesthesia - a Randomized Controlled Trial","MINA","Inclusion Criteria:\n\n* Undergoing anesthesia for medical procedure\n\nExclusion Criteria:\n\n* Does not understand Icelandic\u002FFinnish","4 Years","8 Years",{"count":759,"type":21},150,[163],"The aim of this randomized controlled trial is to evaluate the effectiveness of an educational health game intervention for children undergoing anesthesia from the perspective of children's anxiety. Participants are divided into three groups: one plays an educational game, another gets similar educational material (story) on a website and the third receives usual care. Anxiety will be evaluated with a standard assessment tool at the medical centre and parents answer questionnaires about themselves and their child. The study is an important step into innovation in the field of patient education where computer games are used to disseminate information, teach salvation and promote faith in the child's own ability and courage. The study will provide important information on children's anxiety for anaesthesia and what the effects of the computer game are compared to other educational methods.",[763,764,765,766,767,768,769],"Health Literacy","Anesthesia","Anxiety","Fear","Attitude","Child Behavior","Health Knowledge, Attitudes, Practice",[771,772,764,773],"Children","Game","Health literacy","2024-09-12",{"date":776,"type":38},"2024-09-19",{"date":778,"type":38},"2022-11-21",{"date":780,"type":21},"2025-05-01",{"name":407,"class":85},""]